Abstract: Example embodiments relate to surgical devices, systems, and methods. The system may include a port assembly. The port assembly may be for use with a surgical arm assembly having a surgical arm and elongated anchor section. The port assembly may include a first main body having an elongated body and a main channel. The main channel may be formed by a portion of an interior surface of the elongated body. The main channel may extend between the proximal and distal ends of the elongated body. The first main body may include an instrument gate secured at a proximal end of the main channel. The instrument gate may include an expandable opening configured to be in a persistently closed position. The expandable opening may be configurable to adaptively expand to a shape of a cross-section of a surgical arm when the surgical arm is inserted through the expandable opening.

Abstract: A urinary catheter support configured to support an indwelling urinary catheter such that the urinary catheter is secured relative to the penis of a male patient includes a flexible main body having an interior size and configured to receive and accommodate the penis of the male patient. A catheter support is located at a front end of the main body and is configured to support a catheter adjacent a longitudinal axis of the main body. A slot extends along the longitudinal axis through the main body and the catheter support. A strap includes first and second end segments and a middle segment between the first and second end segments. The first and second end segments respectively extend through first and second openings in the main body, and the middle segment extends through an interior of the main body.

Abstract: The invention includes a transradial introducer sheath support and integral hemostasis device. The device includes a wristband and an introducer sheath support mount attached to the wristband. The wristband is made from a flexible and resilient material that is applied to the distal forearm of the patient or other desired location on the patient. The support mount may be a molded unitary structure, such as made from a thermoplastic material, and is attached directly to the outer surface of the wristband. An inflatable hemostatic element is incorporated in the wristband and mounted to an interior surface of the wristband. The hemostatic element may be selectively inflated to apply pressure to a radial access point of the patient during and after removal of the transradial introducer sheath from the patient. Another embodiment provides a hemostatic element by a rotatable clasp of the sheath support mount.

Abstract: A sheath for a surgical instrument may include a sleeve having a distal end and proximal end, and a retention mechanism at a proximal end portion of the sleeve. The retention mechanism may comprise a sleeve attachment portion configured to be attached to the sleeve at the proximal end portion, and a locking collar extending from the sleeve attachment portion, wherein the locking collar is configured to receive a connector portion of a surgical instrument. The locking collar further may include a locking feature movable between a first configuration, in which the sheath is moveable relative to the surgical instrument, and a second configuration, in which the locking feature is configured to engage with the connector portion to retain the sheath in position on the surgical instrument.

Abstract: A device is disclosed that includes a bone stent positioned within a bony access channel formed within a vertebra. The bony access channel may extends from an outer end of the vertebra through an endplate. The device includes an end cap attached to a proximal end portion of the bone stent and is configured to, post-operatively, open to allow a reintroduction of a material to a spinal intradiscal space or intervertebral disc and to seal access to the spinal intradiscal space or the intervertebral disc after the reintroduction of the material.

Abstract: A concealable feeding tube assembly includes a tube and a removable member. The tube has an insertion portion and a feeding portion respectively at two ends thereof. The feeding portion is configured for insertion into a nasal cavity of a patient and intercommunicates with the insertion portion. The removable member is detachably attached to the tube and is configured to seal the feeding portion. The removable member includes an abutment portion extending beyond a lateral face of the removable member.

Abstract: In various examples, a suture anchor includes a sheath including a lumen. A frame member is disposed at least partially within the sheath. The frame member includes at least two suture loops extending from the sheath. The suture loops are configured to receive a suture, wherein tightening of the suture causes compression of the frame member to constrict the lumen of the sheath.

Abstract: A wearable mobile continuous ambulatory peritoneal dialysis (mCAPD) system, includes an mCAPD module mounted on a front portion of a wearable belt, wherein the mCAPD module comprises a micro-peristaltic pump disposed in a corresponding front portion, and an electronic control board connected to the micro-peristaltic pump for controlling and managing the mCAPD process, a fluid bag containing a dialysate fluid, attached to the wearable belt and to the electronic control board, and a sterile connector having a tube portion fixed into a guide section of the micro-peristaltic pump, and a first connecting end for connecting to a first tube inserted into a peritoneum cavity of the human body, and a second connecting end for connecting to a second tube attached to the fluid bag. Upon rotation, the micro-peristaltic pump enables a flow of fluid between the peritoneum cavity and the fluid bag.

Abstract: A securement device holds a medical article having flexible portions in position upon the body of a patient and inhibits movement of the medical article. The medical article may be insertable into the securement device from above, from below, or along a longitudinal axis of the device. The securement device may have abutment surfaces which interact with the flexible portions of the medical article to further inhibit rotation of the device.

Abstract: The present invention pertains to a device for securing a medical implement to the body of a patient. The device preferably comprises a base having a locking device and an articulation strap connected to a cover. The cover further comprises a gear rack, where the gear rack is insertable into the locking device. The base further comprises a top surface with an adhesive film and release paper and a bottom surface attached to a patient attachment member. The base also has a cutout section. The base is preferably sloped at an angle between five and ten degrees. The cover preferably has at least two living hinges and the articulation strap has at least two living hinges. The locking device further comprises a sliding surface.

Abstract: A system for detecting needle dislodgement includes a first sensor element, a second sensor element, and an alarm. The first sensor element attaches to an associated dialysis tubing having a needle connected at one end. The first sensor element also attaches to the associated dialysis tubing offset from the needle and a sterile field, which is an area on a leg or arm adjacent to where the needle is inserted, in a manner such that movement of the associated dialysis tubing results in movement of the first sensor element. The second sensor element secures to the arm or leg offset from the sterile field. The alarm is in communication with or includes at least one of the first sensor element and the second sensor element. The alarm generates a signal indicative of a position of the first sensor element with respect to the second sensor element.

Abstract: A method for implanting a wireless neural stimulator device, the method including: inserting a device through on a patient's skin on a posterior side of the patient's neck region, wherein the device includes a proximal end, a distal end, a first opening at the proximal end, a second opening at the distal end, and a lumen extending between the first opening and the second opening; after inserting the device through the patient's skin, advancing the distal end into the epidural space of the patient; inserting the wireless neural stimulator device through the first opening; advancing the wireless neural stimulator from the first opening through the lumen until the wireless neural stimulator exits the second opening and into the patient's epidural space; and advancing the wireless neural stimulator through the epidural space until a target site is reached.

Abstract: A method of coupling an extension set hub comprising a blunt cannula, with an infusion set comprising a base, an upper septum, a lower septum, and a septum cap enclosing said upper and lower septa, said septum cap comprising at least one radial port and at least one axial port, the method comprising the steps of affixing said base to a skin surface of a user, moving said extension set hub in a direction substantially parallel to said base until said blunt cannula passes through said radial port and between said upper septum and said lower septum within said septum cap, and rotating said extension set hub about said base until reaching a desired position.

Abstract: The present technology relates to systems and methods for managing core body temperature in a subject using, for example, an esophageal heat exchange device. In one aspect, the disclosure provides a method for reducing duration of a hospital stay in a subject undergoing core body temperature management.

Abstract: A retention member (1) for securing a catheter (2) on a patient (P) comprises a base element (10) having a bottom side (103) and a top side (104), the bottom side being placeable on the patient (P) and the top side (104) being adapted for receiving the catheter (2). The retention member (1) furthermore comprises a ribbon (14) having a first end (140) connected to the top side (104) of the base element (10) and having a second end (141) opposite the first end (140), wherein the base element (10) comprises at least one opening (150, 151) through which the second end (141) of the ribbon (14) is insertable for fixing the catheter (2) on the retention member (1) in between the base element (10) and the ribbon (14). In this way a retention member is provided which is easy and safe to use, may suit to secure catheters of different sizes on a patient and at the same time may be manufactured in a cost-effective manner.

Abstract: A catheter hub for use with a medical device and a catheter, the hub includes a hub body defining a fluid passageway in communication with a first aperture. Optionally, the hub body defines a second aperture that intersects the first aperture. The hub body attaches to the catheter wherein the fluid passageway and the catheter are aligned for fluid flow therethrough. The first aperture extends from and communicates with the fluid passageway to an exterior surface of the hub body and the first aperture configured to receive the medical device. The second aperture extends from and communicates with the first aperture and the exterior surface. A sealing element is sized for and positioned in either the first or the second apertures. The sealing element is configured to receive the medical device and seal both of the first and the second apertures.

Abstract: A system for measuring and monitoring wound hermaticity of a patient is provided that includes one or more sensors for measuring parameters that correlate to a degree of wound hermaticity, where the one or more sensors are incorporated into the design of a percutaneous skin access device (PAD), a bone anchor, a wound dressing, or a bandage. The degree of wound hermaticity is related to impedance measurements performed on the patient's skin, via measurements of humidity in a vacuum line to the PAD or the bone anchor, or via measurements of local tissue oxygenation in the immediate vicinity of the PAD or the bone anchor interface with the patient's skin. The hermaticity measurement parameters are communicated by wired or wireless connection to a computing or a communication device for immediate or remote monitoring.

Abstract: A trocar includes a puncturing device and a sleeving component. The puncturing device includes a base and a puncturing portion. The puncturing portion includes a bump and a tip. The bump extends from an outer surface of the puncturing portion radially. The sleeving component includes a gas pressure base, a first tube assembly, a second tube assembly, and a fixation base. The second tube assembly is retractable. The fixation base is fixed to the second sleeving end and includes a guiding groove and a key groove. The guiding groove communicates the key groove. While the bump of the puncturing device is entered through the guiding groove, and the puncturing device is rotated to have the bump be in the key groove, the puncturing device is secured to the fixation base, and the puncturing device drives the fixation base to move along an elongated direction of the puncturing device.

Abstract: A retention device for anchoring indwelling catheters, sheath introducers, feeding tubes, ostomy bags or other medical devices beneath the skin of a patient includes an deployable section coupled to a medical device; following introduction into a patient, the deployable section is subcutaneously deployed, securely anchoring the device and coupled medical device for the duration of treatment.

Abstract: The present invention pertains to a device for securing a medical implement to the body of a patient such as an IV catheter. The device preferably comprises a base with an insertion site viewing window connected to a luer interconnection cushion at an articulation point and separated from the cushion by a gap. The bottom surface has an adhesive. The device further has a cover with a luer interconnection window, where the bottom surface of the cover also has an adhesive to secure a luer lock of a catheter. The device can also be placed on the Luer interconnection cushion to secure a central IV catheter. The device preferably is made of adhesive foam padding and the insertion site window is polyurethane film. The cover can be connected to the cushion at a lateral pivot. The device can be stored on release paper until used.

Abstract: A medical article, such as a catheter hub or extension set, is stabilized on a patient with a retainer and a dressing integrally attached to an anchor pad supporting the retainer. The catheter hub or extension set may be integrally formed with the retainer. The retainer may comprise a channel and an integral strap. The channel may include an abutment. One or more of the anchor pad, dressing, and catheter may comprise an antibacterial or antimicrobial agent.

Abstract: Disclosed herein are multiple cannulas defining a lumen sized and dimensioned to receive one or more medical instruments, an inflatable outer membrane attached to an outer surface of the cannula, and at least one activator that reversibly activates the cannulas to push a fluid contained in the cannulas into the outer membrane to fill or pressurize the outer membrane. Also disclosed are methods for operating these cannulas.

Abstract: Some embodiments of a medical device anchor system include an anchor device that receives a catheter (or other medical instrument) and secures the catheter in place relative to a skin penetration point. In some embodiments, the anchor device can secure the catheter in an operative position relative to the skin without the use of sutures or skin tapes. In particular embodiments, the anchor device can be adjusted to a folded condition so that subcutaneous anchors are partially rotated prior to removal from the skin penetration point.

Abstract: A system and method for improving limb function through the use of percutaneous mechanical and neural interfaces. The system generally uses a hollow long bone axial rod that is inserted into the long bone medullary cavity. A transfer rod with a central channel is mounted to the long bone axial rod. An exterior body attachment is connected to the transfer rod and attachment rings attach muscle groups, fascia layers and dermal layers to the transfer rod. Additionally, the system is configured to collect and transmit nerve signaling data to an external processor and additionally configured to transmit data from the external processor to the plurality of nerves.

Abstract: The invention provides a catheter including: a first lumen adapted for draining a first fluid from a subject; a second lumen adapted for passing a second fluid through the second lumen; and a third lumen adapted for passing a third fluid through the third lumen such that the third fluid can exit the third lumen to bathe at least a part of an outside surface of the catheter. The invention further provides a kit and/or system including said catheter and method of use for said catheter.

Abstract: A retaining device is disclosed. The retaining device is made of suitable material formed in a frame having a central portion and two opposing arms spaced apart from the frame and in the plane thereof. The central portion being arranged so as to cause a conduit inserted through the cord slots between the central portion and the opposing arms to be urged substantially equally against the opposing arms. Each opposing arm provides a tapered gripping edge directed toward the central portion, wherein each gripping edges provides a plurality of serrations for further engaging the urged conduit.

Abstract: A burr cap assembly is at least partially inserted into a burr hole within the cranium of a patient. The burr cap assembly enables a elongate member to be inserted through the burr cap assembly to access a brain of the patient. A shifting member of the burr cap assembly may be configured to enable the elongate member to move with shifting fluid and matter of the brain. The shifting member of the burr cap assembly may be configured to move within a cavity defined by the burr cap assembly. The shifting member may be configured to move in a direction that is substantially perpendicular to a longitudinal axis of the distal portion of the elongate member. The shifting member may at least partially retain the elongate member, so as the shifting brain applies forces upon the elongate member, the elongate member and the shifting member may move within the cavity.

Abstract: An apparatus for fastening around a cranial burr hole includes a substantially flat core and a shell encapsulating a ring portion of the core. The shell defines an orifice substantially centered within the ring portion, and has a contoured lower surface to match the cranial curvature. Pliable arms of the core extend laterally from the ring portion, each being terminated by a fastener member. A central portion of a placement tool for the apparatus has a lower part configured to extend through the apparatus orifice, and an upper part from which first and second arms of the tool extend laterally. Each tool arm is terminated with a receptacle to hold a bone screw, and, when the tool central portion lower part extends through the apparatus orifice, each receptacle aligns with a corresponding fastener member, and lower openings of the receptacles are generally oriented along the contoured lower surface.

Abstract: In one embodiment the apparatus includes a first retractor, a second retractor, and a shaft. The shaft defines a central channel extending from a first end portion of the shaft to a second end portion of the shaft. The first retractor and the second retractor are configured to collectively form a lumen. The shaft is configured to be disposed within the lumen. In one embodiment method of disposing a graft within a body of a patient, includes making an incision in the body of the patient, inserting a medical device into the body of the patient through the incision, removing the shaft of the medical device from the body of the patient, and moving the first refractor within the body of the patient away from the second retractor.

Abstract: Surgical tools with an upwardly extending tubular support member having a longitudinally extending open channel are provided/described. The tubular support member has a wall surrounding the open channel. The tubular support member may include a base pivotably attached to the tubular support member so that a pivot axis extends above the bottom surface of the base across a bottom portion of the tubular support member to allow the tubular support member to pivot back and forth over a bottom surface of the base. The tubular support member can cooperate with downwardly extending k-wires that anchor to patient bone and/or a strap. One or all of the base, strap and/or k-wires may be used with surgical tools for treating back pain use a spinal facet debridement tool with cautery and denuding action and minimally invasive protocol that can denude and cauterize soft tissue associated with a synovial capsule of the spinal facet joint.

Abstract: Techniques, systems and apparatus for anchoring a therapy delivery device within a body portal are disclosed. An anchoring apparatus may comprise a first part comprising an outer sidewall and opposing grip surfaces. The outer sidewall may extend around a longitudinal axis of the apparatus to define an outer perimeter, at least a portion which may engage a surface of the body portal. A second part may comprise first and second activation members and a slot configured to receive the therapy delivery device. When the therapy delivery device is received in the slot and the second part is moved generally along the longitudinal axis, the first and second activation members may move the opposing grip surfaces toward one another to thereby anchor the therapy delivery device between the opposing grip surfaces.

Abstract: Devices, assemblies, and methods for fitting and maintaining medical lines are shown and described. In one embodiment, a fitting system includes a housing having a spool and a removable upper cover to secure medical lines without obstructing flow. Other embodiments include a catheter assembly having a peripherally inserted central catheter and a housing fitting. Certain peripherally inserted central catheters include an inactive anchor. The result is devices and methods to improve medical line fitting, placement, advancement, and stability.

Abstract: Embodiments include a catheter anchoring device for securing a percutaneous medical catheter inserted at a skin puncture site to a skin of a body. The catheter anchoring device may include a catheter capture portion coupled to a skin attachment portion. The catheter capture portion may be configured to engage with a portion of the catheter protruding from the skin when the catheter is subcutaneously placed in a body. The skin attachment portion may be configured to adhesively attach the anchoring device to the skin, wherein the skin attachment portion is primarily attached to the skin overlaying and lateral to the subcutaneously located catheter.

Abstract: In accordance with an aspect of the present disclosure, an apparatus for suturing tissue is provided that includes a body having a proximate end and a distal end. A suturing head is coupled to the distal end of the body, including a first set of curved needles, a second set of curved needles, and a plurality of sutures. A first end of a suture is coupled to one of the curved needles of the first set. A second end of the suture is coupled to one of the curved needles of the second set. The curved needles of the first set are oppositely oriented to the curved needles of the second set. The suturing head can be positioned between two substantially parallel sections of tissue. An actuator is coupled to the body to deploy the first and second sets of curved needles.

Abstract: In some examples, a catheter includes a catheter body including an outer jacket and an inner liner. The inner liner may include a proximal section including a proximal end of the inner liner and a distal section including a distal end of the inner liner. The distal section may include an inner liner defining a plurality of cuts. Each cut may extend at least partially through the liner wall. The one or more cuts defined in the liner wall of the distal section of the inner liner may increase a bending flexibility of the distal section relative to the proximal section of the inner liner, while maintaining a suitable tensile strength of the distal section.

Abstract: A safety needle assembly of an infusion set is disclosed. The needle assembly is configured to prevent fluid/vapor escape therefrom so as to reduce or prevent fluid exposure to a clinician using the needle assembly. In one embodiment, the needle assembly comprises a handle portion including a needle extending therefrom, the needle defining a lumen for passage of a fluid therethrough. The needle assembly also includes a safety assembly defining a needle hole through which the needle initially extends. The safety assembly is selectively and axially slidable along the needle in order to shield a distal tip of the needle and prevent user contact therewith. A fluid isolation component is included in the safety assembly for isolating fluid escape from the needle. In another embodiment, an interface pad is included on the bottom of the needle assembly and includes an antimicrobial and/or haemostatic agent to protect the needle insertion site.

Abstract: A securement device for retaining medical tubing, catheters, and other medical fixtures proximal a patient's skin. The device has a base, at least one channel formed in the base, a flexible strap for overlying the base, and a coupling assembly for coupling the strap to the base. Embodiments for use with Foley catheters include a plurality of channels of differing diameters. Embodiments for use with a peripheral catheter include a single channel for retaining a spin nut. The coupling assembly includes left and right tracks in left and right sides of the base, and left and right rails on an underside of the flexible strap at left and right ends of a body of the strap. The left rail is removably coupled and held within the left track on the base, and the right rail is removably coupled and held within the right track on the base.

Abstract: The present invention relates to devices and processes for introducing and maintaining a port in an umbilical vessel and uses thereof. Further the invention relates to kits comprising said device and the uses thereof.

Abstract: A multifunction pack frame is disclosed. The pack frame is convertible to provide a backrest and seating combination to the user. The pack frame also provides a variety of firearm aiming support arrangements.

Abstract: An inserter assembly for continuous glucose monitoring with medication delivery capability where the assembly has a deployment button containing a needle deployment mechanism having a sharp held in a pre-release position, a housing body in which the deployment button is movably received within a top end of the housing body, the housing body having a sensor deployment assembly containing a lumen and a sensor disposed within the lumen and extending out of the lumen to a circuit board that is part of the sensor deployment assembly, the sensor deployment assembly matingly connected to the sharp where the sharp extends beyond the sensor deployment assembly and contains the sensor not fixedly attached to the sharp, and a sensor housing releasably received within a lower end of the housing body, the sharp extending into a sensor deployment assembly recess within the sensor housing and directly above a sensor opening in a bottom of the sensor housing.

Abstract: A balloon can be rather easily pressed against an inner wall inside a lumen using a proper pressing force. A balloon has a dilating/deflating section that forms a hollow internal space, and that deflates by the internal space being decompressed, and a support section that is arranged in the internal space so as to deflate in response to the deflation of the dilating/deflating section, and that supports the dilating/deflating section so as to dilate outward in a state where the internal space is under atmospheric pressure.

Abstract: Biliary diversion catheters for diverting bile fluid from a part of the patient's biliary tree to the patient's distal small intestine. The catheter comprises a system of interconnected or interconnectable tubes: a biliary tube segment, an intestinal (e.g. ileal or jejunal) tube segment, and a flush tube segment. The biliary diversion catheter is designed such that bile fluid flows into the biliary tube segment and is shunted into the distal small intestine via the intestinal tube segment. The flush tube segment is used to infuse flush fluid into the catheter (e.g. to clear out any debris within the tube system of the catheter). The biliary tube segment and the intestinal tube segment may together form a drainage tube or an anastomotic component. The flush tube segment and the intestinal tube segment may together form a transabdominal tube.

Abstract: A method of preparing a transplant site for cellular transplantation in a mammal includes the steps of inserting a foreign body comprising a biomaterial into an internal tissue; and removing the foreign body after the tissue surrounding the foreign body has undergone an inflammatory response but before significant fibrous encapsulation has occurred, leaving a neovascularized lumen suitable to receive transplanted cells or islets.

Abstract: A catheter insertion device (18) includes a housing (12) with a base (14), a catheter (28), an introducer needle (30) and an actuator (26) mounted within the housing. The catheter (28) and needle (30) are coupled to the actuator (26) and movable between a first position where the catheter and needle are retracted within the housing and a second position where the catheter and needle extend from the housing, and where the needle retracts into the actuator when the catheter and needle reach the second position. The actuator (26) has a detent (84) that engages a first recess (76) to require a predetermined force to depress the actuator (26) which is greater than the force necessary to slide the actuator (26) to the second position where the detent (84) engages a second recess (80) in the housing (12) to hold the actuator in the deployed position.

Abstract: In some embodiments a PEG feeding device includes a tube sized to bridge a channel between a stomach and an outer abdominal surface; an internal bolster, and an external bolster. Optionally the bolsters are connected to the tube. The internal bolster may be sized to resist movement out of the stomach through the stoma. The external bolster may be sized to resist movement into the stoma from the outer abdominal surface. The external bolster may include an underside which extends from the tube in a radial direction between the external bolster and the outer abdominal surface. The underside of the outer bolster may contact the outer abdominal surface at a distance from an external opening of the stoma. Optionally the distance between the internal bolster and the external bolster is adjustable. Optionally an angle between one or both of the bolsters and the tube is adjustable.

Abstract: Some embodiments of a medical device anchor system include an anchor device that secures a medical instrument (such as a catheter or the like) in place relative to a skin penetration point using subcutaneous anchors. In some implementations, the medical instrument can be coupled to the anchor device using a snap-lock cap mechanism.

Abstract: A device (10) for delivering a fluid includes a housing (12) defining an interior space (22) and having a bottom surface (18) configured for contacting a patient. The bottom surface (18) defines a needle opening (56). The device (10) also includes a reservoir (26) disposed within the interior space (22) of the housing (12) for containing a fluid therein, a needle carrier (30) disposed within the housing (12), and an injection needle (28) supported by the needle carrier (30) and defining a lumen. The lumen of the injection needle (28) is configured to be placed in fluid communication with the reservoir (26).

Abstract: Some embodiments of a medical device anchor system include an anchor device that receives a catheter (or other medical instrument) and secures the catheter in place relative to a skin penetration point. In some embodiments, the anchor device can secure the catheter in an operative position relative to the skin without the use of sutures or skin tapes. In particular embodiments, the anchor device can be adjusted to a folded condition so that subcutaneous anchors are partially rotated prior to removal from the skin penetration point.

Abstract: A vial gripper and gripper assembly having a base and a clamp extending therefrom made from an elastomeric material. The clamp adapted to retain a vial, ampoule, or other containers therein typically used in the hospital or clinical setting. The gripper assembly includes an elevated body having a guide wherein a gripper is insertable, and wherein the assembly may be further securely stored within a unit tray.

Abstract: Stomach tissue is manipulated to form, for example, a restored flap of a gastroesophageal flap valve. The manipulation includes gripping stomach tissue from within the stomach while the stomach is inflated to promote visualization and stabilization of the gripped stomach tissue. Once the stomach tissue is gripped, the stomach is deflated and pulled into a mold. The molded tissue is then fastened with at least one fastener. The stomach is inflated to a first pressure during visualization and then to a second higher pressure during the stomach tissue gripping.